Because Diversity In Clinical Trials is Essential…
The mission of the Thurston Arthritis Research Center (TARC) is to provide quality care, healing, and hope to patients with arthritis, allergies, and autoimmune diseases. As such, leveraging advanced research to explore the origins and impacts of these diseases on patients and society is at the core of the TARC philosophy.
Unfortunately, it is widely recognized that minority groups have been historically underrepresented in clinical trials, which has resulted in a deficiency of data supporting treatment options for these groups. Congress, the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) have successfully combined efforts to mitigate this shortage of data; however, the challenge of obtaining data of sufficient statistical power across ethnic, racial, and socioeconomic lines remains.
Clinical investigators occupy a unique space as leaders of research with large populations. The following resources outline several simple, yet effective best practices for diversifying clinical trials that clinical investigators can readily adopt. It is our hope that these resources will be useful points of reference in conducting clinical trials across diverse demographic groups.
Diversity Resources and Links You Can Use…
This is an extensive overview of the major barriers to minority group inclusion in clinical trials, as researched by the Endocrine Society. It also outlines recommendations for clinical study reports, participant selection and enrollment, and transparent data analysis regarding ethnic subpopulations.
This resource is tailored towards both healthcare providers and investigators with suggestions for forging and maintaining partnerships with community organizations serving minority groups. It also has guidelines for developing targeted public health education programs to reach individuals who experience disparities based on disease distributions.
Under NIH Guideline on the Inclusion of Women and Minorities as Subjects in Clinical Research, there are suggestions specific to research plans concerning phase I/II trials.
- Outreach Notebook for the Inclusion, Recruitment, and Retention of Women and Minority Subjects in Clinical Research
This resource illustrates detailed research protocols concerning women and minorities, including research plans, design of recruitment and evaluation, and tips for establishing and maintaining communication to increase project awareness across racial and ethnic lines.
This resource provides information in an effort to promote the improvement of women’s health through science, policy, and education. In particular, SWHR published a paper, Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials, which links to several organizations dedicated to training female and minority investigators including the National Clinical Trials Network, National Minority AIDS Council, National Hispanic Research Network. It also links to clinical trials that have demonstrated multisector collaborations and extensive engagement with minorities. Towards the end of the article, there are recommendations for study design and ethical considerations.
This resource focuses mainly on building rapport with the African American community through technological engagement, particularly via databases matching patients with clinical trials, such as the NIH All of Us initiative health database. These databases are potentially valuable methods to increase minority access to novel clinical trials.
- Enhancing the Diversity of Clinical Trial Populations- Eligibility Criteria, Enrollment Practices, and Trial Designs
This resource effectively differentiates between the traditional investigator-driven model for patient recruitment vs. the innovative community-driven approach (figure 1). Under the community-driven approach, there are recommendations for developing cultural humility through communication and improving representation of diverse patients in trials through community and study-based methods.
This is a resource for grassroots level analysis of barriers and potential solutions, including an accessible flowchart pinpointing overarching themes related to common barriers. Additionally, this source outlines a concise “Clinical Trials Roadmap to Success” and “Inclusive Clinical Trial Implementation Checklist” with pointers for patients, referring physicians, investigators, and study coordinators. They are invaluable guides for investigators throughout the process.
The CDC has a variety of resources relating to health equity, including an e-newsletter, conversations in equity, and reports on health disparities/strategies. Notably, this source contains updated information on recruiting minorities for clinical trials in the time of COVID-19.
A literature review on some of the most pertinent ethical considerations for investigators in the field of basic sciences research. It includes pointers on engaging in critical reflection on how the history of clinical research combined with contemporary trends have affected investigator hypotheses, assumptions, and tools.